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FDA releases new patient guidance on biosimilars

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

Novo Nordisk to launch biosimilar insulin in the US

Novo Nordisk has announced plans to launch biosimilar versions of its NovoLog and NovoLog Mix insulin products in the US in January 2020.

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegfilgrastim biosimilar, Fulphila.

Canadian IBD charity updates biosimilar position statement

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of its biosimilar Erlezi.

Momenta drops Humira biosimilar development

Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.

Australia approves three biosimilars in first half of 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.

Biosimilars applications under review by EMA – July 2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

South Korea’s Celltrion to sell directly to Australia

In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.

NHS England updates its ‘What is a Biosimilar Medicine?’

The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.